Phase 3 Lung Cancer Trial, Recruiting NCT04316364 Sponsor: Jiangsu HengRui Medicine Co., Ltd. Condition: Lung Cancer
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Phase 3 Lung Cancer Trial, Recruiting

NCT04316364
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are in good general health and able to carry out daily activities with little or no limitation (based on a standard cancer health scoring system called ECOG, scores 0 or 1)
  • People who have been diagnosed with a confirmed, early-to-intermediate stage non-small cell lung cancer (Stage II, IIIA, or certain Stage IIIB) that has not yet been treated, based on a specific staging system (8th edition AJCC/UICC)
  • People whose lung cancer has been assessed by a chest surgeon as suitable for an operation to remove all of the cancer with the goal of cure
  • People who have a tumour tissue sample available for a specific laboratory test (PD-L1 testing) at a central lab
  • People whose cancer can be measured on scans according to standard criteria (RECIST v1.1)
  • People whose organs (such as liver, kidneys, and blood cells) are functioning at an adequate level
  • Women who could become pregnant and men must agree to use contraception or abstain from sex for at least 180 days after the last dose of the study treatment

Who may not be able to join:

  • People who have previously received any systemic anti-cancer treatment for lung cancer
  • People who have an active, known, or suspected autoimmune disease (a condition where the immune system attacks the body)
  • People who have had a different type of cancer within the past 5 years (other than the non-small cell lung cancer being studied)
  • People who have a history of, or are suspected to have, lung inflammation (pneumonitis), scarring of the lung tissue (interstitial lung disease), or other serious lung conditions that could affect lung function testing
  • People with a significant history of heart or stroke-related disease
  • People with a significant history of serious bleeding disorders
  • People who have had blood clot or blood vessel-related events (confirm with trial site)
  • People who have a known history of HIV infection
  • People who have active Hepatitis B or Hepatitis C infection
  • People who are allergic to monoclonal antibody medicines or similar protein-based drugs
  • People who are allergic to any of the medicines used in this trial
  • Women who are pregnant or currently breastfeeding
  • People who have a known psychiatric illness or substance abuse disorder
  • People who have a confirmed or suspected COVID-19 infection, or who have had close contact with someone with known or suspected COVID-19

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 2 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Registry
ClinicalTrials.gov
Start date
14 July 2020
Est. completion
15 April 2023

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Major pathological response rate (MPR); Event free survival (EFS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov